MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA PLUS VASCULAR COVERED STENT

Catalog Number AASME08080

Device Problem Obstruction of Flow (2423)

Patient Problem Stenosis (2263)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the covera plus vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent are identified.As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 02/2022).Device not returned.

Event Description

It was reported that post stent graft deployment procedure, allegedly there was in-stent stenosis in the proximal part of the stent.The patient status was unknown.

Event Description

It was reported that post stent graft deployment procedure, allegedly there was in-stent stenosis in the proximal part of the stent.The patient status was unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera plus vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent are identified in d2 and g4.H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the physical device was not returned for evaluation and no x-ray images were provided.Based on the investigation of the provided information, the investigation is closed as inconclusive.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the 'restenosis' as one of its potential complications.The covered stent specific events which may led to the clinical potential complications are stated in the instructions for use as: embolism; fracture; insufficient covered stent expansion; kinking; malposition; migration and misplacement; and side branch occlusion.In the same way, the delivery system specific events which could be associated with the clinical potential complications are stated as: blood leakage from delivery system; bond joint failures; delivery system kinking; detachment of parts; failure to deploy; high deployment forces; inability to track to target location; inaccurate deployment; incompatibility with accessory devices; no visibility under fluoroscopy; and premature deployment.H10: d4 (expiry date: 02/2022), g3.H11: h6 (method).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: COVERA PLUS VASCULAR COVERED STENT
• Type of Device: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 12365724
• MDR Text Key: 268071768
• Report Number: 9681442-2021-00453
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASME08080
• Device Lot Number: ANDV1844
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR